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Trial record 35 of 144 for:    "Acute promyelocytic leukemia"

Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Promyelocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002701
Recruitment Status : Unknown
Verified November 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : April 11, 2003
Last Update Posted : September 20, 2013
Sponsor:
Collaborator:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy to kill tumor cells. It is not yet known which regimen of combination chemotherapy with or without bone marrow transplantation is more effective in treating promyelocytic leukemia

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens with or without bone marrow transplantation in treating patients who have promyelocytic leukemia.


Condition or disease Intervention/treatment Phase
Leukemia Drug: busulfan Drug: cyclophosphamide Drug: cytarabine Drug: etoposide Drug: idarubicin Drug: mercaptopurine Drug: methotrexate Drug: mitoxantrone hydrochloride Drug: thioguanine Drug: tretinoin Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Radiation: radiation therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: INDUCTION WITH ALL-TRANS RETINOIC ACID IN COMBINATION WITH IDARUBICIN AND INTENSIVE CONSOLIDATION FOLLOWED BY BONE MARROW TRANSPLANTATION OR A RANDOMIZED MAINTENANCE TREATMENT DEPENDING UPON THE AMOUNT OF MINIMAL RESIDUAL DISEASE IN ACUTE PROMYELOCYTIC LEUKEMIA
Study Start Date : October 1995






Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 74 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed acute promyelocytic leukemia
  • Must have promyelocyte-retinoic acid receptor alpha transcript at disease presentation

PATIENT CHARACTERISTICS:

Age:

  • 16 to 74

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 3 times upper limit of normal (ULN)
  • AST no greater than 3 times ULN
  • Alkaline phosphatase no greater than 3 times ULN

Renal:

  • Creatinine no greater than 2.5 mg/dL

Cardiovascular:

  • No cardiac contraindication to anthracycline chemotherapy

Other:

  • No active serious infection not controlled by antibiotics
  • No severe concurrent psychiatric disease
  • No other malignancy except basal cell carcinoma
  • Not pregnant or nursing
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No concurrent cytotoxic chemotherapy

Endocrine therapy:

  • Prior corticosteroids for leukemia allowed

Radiotherapy:

  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • No prior antileukemic therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002701


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Locations
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Austria
Innsbruck Universitaetsklinik
Innsbruck, Austria, A-6020
Belgium
Algemeen Ziekenhuis Middelheim
Antwerp, Belgium, 2020
A.Z. St. Jan
Brugge, Belgium, 8000
C.H.U. Saint-Pierre
Brussels (Bruxelles), Belgium, 1000
Institut Jules Bordet
Brussels (Bruxelles), Belgium, 1000
Hopital Universitaire Erasme
Brussels, Belgium, 1070
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
CHU Sart-Tilman
Liege, Belgium, B-4000
Centre Hospitalier Peltzer-La Tourelle
Verviers, Belgium, B-4800
Croatia
Medical School/University of Zagreb
Zagreb (Agram), Croatia, 41000
University Hospital Rebro
Zagreb, Croatia, 41000
Czech Republic
Onkologicka Klinka A Onkologicka Lab
Prague, Czech Republic, 128 08
France
Centre Hospitalier Regional de Lille
Lille, France, 59037
Hopital Edouard Herriot
Lyon, France, 69437
Centre Antoine Lacassagne
Nice, France, 06189
Hotel Dieu de Paris
Paris, France, 75181
Hopital Necker
Paris, France, 75743
Centre Medico-Chirurgical Foch
Suresnes, France, 92151
Institut Gustave Roussy
Villejuif, France, F-94805
Germany
Klinikum Duisburg
Duisburg, Germany, D-47055
Klinikum Grosshadern
Munich (Muenchen), Germany, D-81377
Italy
Ospedale Civile Alessandria
Alessandria, Italy, I-15100
Ospedale Torrette University Ancona
Ancona, Italy, 60020
Ospedale Civile Avellino
Avellino, Italy
Universita Degli Studi di Bari Policlinico
Bari, Italy, 70124
Ospedale Regionale A. Di Summa
Brindisi, Italy, I-72100
Ospedale Oncologico A. Businco
Cagliari, Italy, 09124
Ospedale Ferrarotto
Catania, Italy, 95124
Ospedale Regionale A. Pugliese
Catanzaro, Italy, 88100
Centro Trapianti di Midollo Osseo
Cremona, Italy, 26100
Ospedale Santa Croce
Cuneo, Italy, 12100
Policlinico di Careggi
Firenze (Florence), Italy, 50134
Ospedali Riuniti Foggia
Foggia, Italy, 71100
Ospedale S. Antonio Abate
Gallarate Varese, Italy, 21013
Ospedale San Martino/Cliniche Universitarie Convenzionate
Genoa (Genova), Italy, 16132
Ospedale Gen. Provinciale Santa Maria Goretti
Latina, Italy, 04100
Ospedale Maggiore Lodi
Lodi, Italy, I-20075
Ospedale Maggiore Ca Granda
Milano (Milan), Italy, 20162
Istituto Scientifico H.S. Raffaele
Milano, Italy, 20132
Ospedale Di Montefiascone
Montefiascone, Italy, I-01027
Azienda Ospedaliera "A. Cardarelli"
Naples (Napoli), Italy, 80127
Federico II University Medical School
Naples (Napoli), Italy, 80131
Ospedale S. Gennora USL 42
Naples (Napoli), Italy, 80136
Ospedale Nuovo Pellegrini
Naples (Napoli), Italy, 80144
Ospedale San Francesco
Nuoro, Italy, 08100
Azienda Ospedaliera di Padova
Padova (Padua), Italy, 35128
Policlinico - Cattedra di Ematologia
Palermo, Italy, 90100
Ospedale Cervello
Palermo, Italy, 90146
Azienda Ospedaliera Di Parma
Parma, Italy, 43100
I.R.C.C.S. Policlinico San Matteo
Pavia, Italy, 27100
Policlinico Monteluce
Perugia, Italy, 06122
Ospedale San Salvatore
Pesaro, Italy, I-61100
Ospedale Civile Pescara
Pescara, Italy, 65100
Ospedale San Carlo
Potenza, Italy, 85100
Ospedale San Eugenio
Rome, Italy, 00144
Azienda Policlinico Umberto Primo
Rome, Italy, 00161
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, Italy, 00168
Ospedale Casa Sollievo della Sofferenza
San Giovanni - Rotondo, Italy, 71013
Istituto di Ematologia Universita - University di Sassari
Sassari, Italy, 07100
Ospedal SS Annunziata
Taranto, Italy, 74100
Cattedra di Immunologia Clinica
Turin (TO), Italy, 10128
Ospedale Molinette
Turin (Torino), Italy, 10126
Netherlands
Leyenburg Ziekenhuis
's-Gravenhage (Den Haag, The Hague), Netherlands, 2545 CH
Groot Ziekengasthuis 's-Hertogenbosch
's-Hertogenbosch, Netherlands, 5211 NL
Academisch Medisch Centrum
Amsterdam, Netherlands, 1105 AZ
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9713 EZ
Leiden University Medical Center
Leiden, Netherlands, 2300 CA
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6500 HB
University Hospital - Rotterdam Dijkzigt
Rotterdam, Netherlands, 3000 CA
Turkey
Ibn-i Sina Hospital, Ankara University
Ankara, Turkey, 06100
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Study Chair: Petra Muus, MD, PhD Universitair Medisch Centrum St. Radboud - Nijmegen
Study Chair: Franco Mandelli, MD Azienda Policlinico Umberto Primo

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ClinicalTrials.gov Identifier: NCT00002701     History of Changes
Other Study ID Numbers: CDR0000064499
EORTC-06952
ITA-GIMEMA-AIEOP-1
First Posted: April 11, 2003    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: November 2006
Keywords provided by National Cancer Institute (NCI):
untreated adult acute myeloid leukemia
adult acute promyelocytic leukemia (M3)
Additional relevant MeSH terms:
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Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Cytarabine
Cyclophosphamide
Busulfan
Methotrexate
Etoposide
Mitoxantrone
Idarubicin
Mercaptopurine
Tretinoin
Thioguanine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites